Minesse ®

Please read this leaflet carefully before taking this medicine.

  • Keep this leaflet. You may have to read it again.
  • If you have any questions, Consult your doctor or pharmacist.
  • This medicine has been prescribed for you Do not pass it on to others, even if their symptoms, as yours.
  • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1. Minesse WHAT IS AND WHAT IT IS USED

Minesse is a hormonal contraceptive low dose oral. Inhibits ovulation. It is used to prevent pregnancy.


2. BEFORE YOU TAKE MINESSE

Minesse not take if you are in any of the following circumstances or have any of the following diseases:
– Known hypersensitivity to any component of Minesse.
– Are you pregnant or might be pregnant
– Severely impaired liver function or liver tumors.
– Venous thrombosis: blood clots in the veins of the lower limbs that have fallen affecting other parts of the body, even if it was long ago. The clot can affect the lungs evolved (pulmonary embolism).
– Lumps in the breasts, Cervical, uterus vagina.
– Diabetes combined with heart problems circulatory problems.
– Disorders of the arteries of the brain or heart (arterial thromboembolism).
– If you have an inherited or acquired predisposition for venous or arterial thrombosis.
– Certain diseases of the heart valves (valvulopatías trombogénicas).
– Heart rhythm disorders with possible blood clots (thrombogenic arrhythmias).
– High Blood Pressure.
– Vaginal bleeding of unknown cause.
– If you have certain types of migraine (migraine with focal neurological signs).

Take special care with Minesse:

Before using Minesse will have to see your doctor to perform a physical examination. It is important to tell if you have or have had in the past any of the diseases listed below. If so, your doctor may have to watch her more often. It should also see your doctor if any of these conditions worse or appears while using Minesse:

– Heart Disease (chest pain, certain types of heart rhythm disorders, heart disease).

– High levels of fat (triglicéridos) blood or family history of this.
– High Voltage, particularly if it worsens or does not improve when taking antihypertensive medications.
– Migraines (migraines) intensive and repetitive.
– Diabetes.
– Depression or history of depression, as this may worsen or come back to use hormonal contraceptives.
– Epilepsy.
– Disturbances in the function of the liver or bile ducts.
– Permanent brown spots on the skin of the face, especially if you've had during a previous pregnancy. If any, Avoid sunlight and ultraviolet radiation (p.ej. solarium).
– Vascular disease, Varicose veins (varicose veins) or kidney disorders.

If you have hereditary angioedema, products containing estrogens may induce or exacerbate symptoms of angioedema. You should see your doctor immediately if you experience symptoms of angioedema such as swelling of the face, lengua y / o faringe, and / or difficulty swallowing or hives together with difficulty breathing.
Also contact your doctor if you think you might be pregnant.

Potentially serious diseases:

Thrombosis (blood clots)
The use of the pill may increase the chance of thrombosis (blood clots).This risk is greatest during the first year of use of contraceptive pills. Nevertheless, the chances of developing blood clots, are higher during pregnancy than during the contraceptive treatment.
Blood clots can block the major blood vessels and very rarely may cause permanent disability or death. If the blood clot forms in the deep veins of the legs, may break off and block the pulmonary arteries (pulmonary embolism). Likewise, Blood clots occur rarely in the heart arteries (myocardial infarction, angina pectoris) or cerebral arteries (cerebral thrombosis).
If you identify the occurrence of any of the possible signs of a blood clot, Tell your doctor. These symptoms are:

– pain and swelling in the leg
– severe chest pain and sometimes in the arm
– cough of acute onset
– severe headache
– vision problems (vision loss, double vision)
– difficulty speaking clearly
– dizziness
– seizures
– weakness or numbness that affects a body part
– difficulty walking or holding things
– severe stomach pain

The following conditions may increase the risk of blood clots, so you must tell the doctor if any of them:

– certain thrombophilias (tendency to produce blood clots hereditary or acquired defect).
– you are very obese.
– Are you a smoker, especially if you have more than 35 años.
– just given birth or just had an abortion in the second trimester of pregnancy.
– needs to be in bed for several days. In these cases, if possible, treatment should be discontinued.
– has undergone or will undergo major surgery. In these cases, whenever possible treatment should be discontinued four weeks before and two weeks after you undergo such intervention.
– migraines (severe pain migraine headache). If you increase the frequency or severity of such treatment should be discontinued with the contraceptive.
– elderly.

To use Minesse after delivery or abortion in the second trimester: see section “3. HOW TO TAKE MINESSE“.

Blood Pressure
If you have hypertension (High Blood Pressure) or disease related to hypertension ( including kidney diseases), is preferable to use other contraceptive methods. If you choose to use oral contraceptives, blood pressure should be monitored, but if it increases, and can not be controlled with medication, need to discontinue treatment.

Tumors
There have been reports of breast tumors with a frequency slightly higher in women using contraceptive pills, but whether this is due to treatment. Por ejemplo, could be that more tumors were detected in women who use birth control pills because they attend more often medical consultation. This increase in frequency gradually decreases after stopping treatment. After ten years, the chances of having breast cancer would be the same for women who have never used birth control pills.
Likewise, cervical tumors (cervix) occur more frequently in women using the contraceptive pill. Nevertheless, the occurrence of this tumor is associated with an increase in sexual activity and sexual transmitted diseases, so it is unclear whether the pill plays a direct role in this risk. On the other hand, oral contraception reduces the risk of ovarian cancer and endometrial.
Rarely been reported liver tumors in women using the contraceptive pill.
This can cause internal bleeding that results in severe pain in abdomen. If this occurs, should contact your doctor immediately. You should ensure close monitoring if you or a relative have or have had breast or benign uterine pathology (endometrial hyperplasia, fibroids), hiperprolactinemia (excess of a hormone called prolactin, blood), otosclerosis (a type of ear disease), suspended, herpes during pregnancy, gallstones, chorea or HUS.

Genital bleeding

You might not have the "period" in the days planned. If the pill is taken correctly, is very unlikely to be pregnant. Nevertheless, if you have two faults, should consult your doctor as you should rule out pregnancy. If you have not taken the pill according to the instructions in "3. HOW TO TAKE MÍNESSE " and has a lack, should discontinue treatment and use a nonhormonal contraceptive method until pregnancy is ruled out.
Minesse can cause unexpected bleeding during the first months of use. If the bleeding lasts more than a few months, or if it begins after a few months, Your doctor should investigate the cause. Errors in the use of the pill can also cause spotting and light bleeding.
Some women may experience amenorrhea (lack of menstrual flow) u oligomenorrhea (decreased menstrual flow) post-therapeutic, especially when there is a history of it. These situations usually resolve spontaneously, but if it were not so you should consult your doctor.
The contraceptive pill does not protect against HIV infection (PAGE) or any other sexually transmitted disease (p.ej. Chlamydia, genital herpes, condyloma acuminata, gonorrhea, hepatitis B and syphilis). You must use condoms to protect against these diseases.

Others
Although not conclusively shown the association with combined oral contraceptives, has been reported both during pregnancy and during the making of these can cause or worsen a picture of cholestasis (arrest or decreased flow of bile into the bile ducts, due to obstruction of hepatic origin or extrahepatic).
Be especially careful with Minesse if you have high levels of fats (triglicéridos) blood or family history of the same. Estrogen preparations may be associated with increases in triglycerides, rare but important, Original pancreatitis can.
Diarrhea and vomiting may reduce the absorption of the contraceptive (see “3. How to take Minesse“).
Tell your doctor if any of the symptoms or risk factors described above.

Pregnancy
Minesse not use if pregnant or think you may be pregnant.
If you become pregnant, must immediately discontinue making Minesse and consult your doctor.

Breastfeeding
Should not be used until the end Minesse fully breastfeeding.

Driving and using machines
You can drive or use any tools while taking Minesse.

Important information about some of the components of Minesse
Polacrilin to contain potassium as an excipient is harmful for patients with potassium diet. Excess potassium may cause, after oral administration, stomach upset and diarrhea.
Tell your doctor if you take Minesse, it may alter the results of certain lab tests or.
If you have questions about any of the above, consult your doctor before taking Minesse. This product contains lactose. If your doctor has told you have an intolerance to some sugars, Consult your doctor before taking this medicine.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. However, see the prospectus of the medications administered simultaneously to identify possible interactions with Minesse.
Note that these instructions may also apply to medicines you have taken can be taken before or after.
The medications listed below may prevent combined hormonal contraceptives work well and, if this occurs, could become pregnant:

– Some treatments for viral infections and HIV (ritonavir).
– Some antibiotics (por ejemplo, ampicillin, rifampin, rifabutina, tetracyclines, griseofulvina, erythromycin).
– Some antiepileptic (topiramate, barbiturates, phenytoin, carbamacepina, primidona, felbamato).
– Antacids.
– others (flunarizina).
– Some substances to lift the spirits (modafinil).

The herb St. John's wort (Hiperium perforatum) also reduces the effect of oral contraceptives and pregnancy have been reported in women taking both the pill and some preparation St John's wort. The decrease of contraceptive effect lasts up to two weeks after he stopped taking the preparation with that St. John's wort.
You should use reliable contraceptive method if you are taking any of the drugs mentioned above. The effect of any of these medications can last up 28 days after stopping treatment.
You should never take another drug on its own initiative without your doctor's advice, since some combinations should be avoided.

3. CÓMO TOMAR MINESSE

Follow these instructions unless your doctor has given you different.
Remember to take your medicine, since the neglect of coated tablets may decrease the effectiveness of the preparation.
This medicine is for oral administration.
Before starting treatment with Minesse the doctor should perform a thorough medical history and a thorough overall and gynecological (including breast), and ruled out the existence of pregnancy.
The tablets are swallowed with a little liquid.
The blister is coated tablets have pointed to the number of 1 the 28, along a direction indicated by arrows. In the center are also 7 empty sockets marked with days of the week.
You then follow the instructions for making the coated tablets:

• Start making Minesse ingesting the tablet marked with the number 1, which is located next to the word "HOME".
• At the same time, as a reminder, drill on the center of the blister, the empty socket marked with the corresponding day of the week.
• Each blister contains 28 coated tablets. Take a coated tablet each day following dcoated rigorously tabletss (yellow coated tablet active during the first 24 days, after, inactive for the white one 4 last days), to terminate 28 coated tablets. Try to take the tablet coated at the same time each day. The hemorrhage of deprivation (rule) usually begins 2-3 days after socket last active tablet (yellow), and may not be completed before starting the next pack. It is important not to forget making any coated tablet (if this occurs, read below
and take appropriate action).
• Once the blister, one must begin again the next day. So always start a new blister on the same day of the previous week beginning. No rest interval, por lo que, is important that before finishing a container, have prepared a new.

El primer cycle with Minesse

If you have not used contraception in the previous month:

Start taking Minesse the first day of menstrual bleeding.
The time of collection of the first coated tablet is indifferent (is best done after breakfast or dinner), but the following should be taken, about, at the same time that the first. Possible forgetfulness or repetitions of the daily intake are easy to avoid taking into account the empty boxes and the weekly calendar printed on the blister.
In subsequent cycles, it does not require rest periods between blisters, to prevent irregularities and olvido en la take, should be prepared before the end of the second blister the first. Must start the day after taking the last white coated tablet blister just ended.

If you switch from another birth control:

• Oral Contraceptives: You must start taking Minesse the day after taking the last active tablet coated his previous oral contraceptive.
• injection or implant: Must start Minesse making the day of implant removal or, if using an injection, the day it should be for the next injection.

Whether you're switching to another oral contraceptive Minesse from as from an implant or injection, it is advisable to use another method of birth control during the 7 early days of making the coated tablet.

After the first trimester abortion:

You can start taking immediately Minesse. No additional contraceptive measures are necessary.

After delivery or abortion in the second quarter:

Should not start before making the day Minesse 21 the 28 after delivery or abortion in the second trimester. It is advisable to use another method of birth control during the 7 early days of making the coated tablet. If you had sex before you start making Minesse, Call your doctor to rule out pregnancy before you start taking the preparation. Your doctor will tell you how long your treatment with Minesse. Do not stop treatment before, Doing so may cause the desired effect.

If you take more Minesse coated tablets than you should

If you take more tablets coated Minesse than you should, immediately consult your doctor or pharmacist or local poison control center. Telephone: (91) 562 04 20.
An overdose can cause gastrointestinal symptoms such as nausea, vomiting, abdominal pain, chest tightness, dizziness, drowsiness / fatigue and can affect the menstrual cycle (indented). Seek advice from your doctor.

If you miss taking a tablet coated Minesse

The neglect of one or more coated tablets may create a risk of pregnancy.
If you miss a yellow coated tablet and realizes within 12 hours after the usual time, Take the missed tablet immediately and follow the treatment normally taking the next tablets at the usual time. Need not take any additional measures.
If you miss a yellow coated tablet and realizes after 12 hours after the usual time, risk of pregnancy. In this case,es: Immediately take the missed tablet, even if it means taking two tablets on the same day, Continue treatment until the end of the container and simultaneously use another birth control method (condom, spermicide) during 7 If days 7 days that is required to use an additional contraceptive method extend beyond the last active tablet taken from the current pack, the next pack should be started the day after taking the last active tablet of the current container, dispose all inactive tablets. It is unlikely that you submit a withdrawal bleed (rule) until the time of making the second container inactive tablets, may have spotted (spotting) or breakthrough bleeding. If you do not have a withdrawal bleed at the end of the second pack must discard a possible pregnancy before proceeding with taking tablets.

Do not use natural methods such as rhythm or temperature, because they can not adequately protect. Once you start the new packaging is already protected again facing the possibility of pregnancy.
The neglect of taking some white-coated tablet is not important, long as the time between taking the last yellow coated tablet and coated tablet takes the first yellow of the next package do not exceed four days.

Gastrointestinal Disorders

The occurrence of vomiting or severe diarrhea in 4 hours after taking the tablet coated can cause transient ineffective contraceptive, because it reduces the absorption of the. In this case, proceed in the same way as in the case where one has forgotten coated tablet for less than 12 hours. The tablet should be taken of additional reserve container. If gastrointestinal problems are repeated over several days, then you must use a non-hormonal contraceptive additional (condom, spermicide, etc.) until the beginning of the next blister.

Sexually transmitted infections

Minesse, like other oral contraceptives, not protect against HIV infection (PAGE) or against other sexually transmitted diseases.

4. Possible adverse effects

Like all medicines, Minesse can have adverse effects.
Some of the most frequently reported adverse events (over 10% Incidence) during Minesse studies are: headache, including migraines, and breakthrough bleeding / stained (spotting).
Others have been reported adverse events during the use of Minesse.
These are listed below ranked by their frequency in patients treated, according to the following criteria:

Neoplasms benign, and unspecified malignant (including cysts and polyps):
– Very rare (< 0,01%): Benign liver tumors (called focal nodular hyperplasia and hepatic adenoma) or malignos.

Common Infections:
– FAQ (> 1% and < 10%) : Vaginitis (inflammation of the vagina), including candidiasis. (fungal infection of the vagina).

Immune system disorders:
– Rare (> 0,01% and < 0,1%) : Allergic reactions like hives(itching), angioedema (swollen face, lips, mouth and very rare cases of serious reactions accompanied by difficulty breathing, dizziness and even loss of consciousness).
– Very rare (< 0,01%) : Exacerbation of systemic lupus erythematosus(inflammatory dermatitis).

Metabolic and Nutritional Disorders:
– Uncommon (> 0,1% and < 1%) : Changes in appetite (increase or decrease).
– Rare (> 0,01% and < 0,1%) : Glucose intolerance.
– Very rare (< 0,01%) : Exacerbation of porphyria (familial metabolic disorder).

Psychiatric disorders:
– FAQ (> 1% and < 10%) : Mood, including depression; changes in libido (sexual desire).

Nervous system disorders:
– Very common (≥10%) : Headache, including migraines(migraines).
– FAQ (> 1% and < 10%) : Nervousness, vertigo.
– Very rare (< 0,01%) : Exacerbation of chorea (involuntary movements).

Eye disorders:
– Rare (> 0,01% and < 0,1%) : Intolerance to contact lenses. – Very rare (< 0,01%) : Eye abnormalities and visual disturbances, such as optic neuritis (optic nerve inflammation) and retinal vascular thrombosis (occlusion of retinal vessels).

Vascular disorders:
– Uncommon (> 0,1% and < 1%) : Increases in blood pressure.
– Rare (> 0,01% and < 0,1%) : Venous thrombotic events (blood clots in veins).
– Very rare (< 0,01%) : Worsening varices.

Gastrointestinal disorders:
– FAQ (> 1% and < 10%) : Nausea, vomiting, abdominal pain.
– Uncommon (> 0,1% and < 1%) : Colic, bloating.
– Very rare (< 0,01%) : Pancreatitis (inflammation of the pancreas).

Hepato-biliary disorders:
– Rare (> 0,01% and < 0,1%) : Cholestatic jaundice (yellowing of the whites of the eyes and skin).
– Very rare (< 0,01%) : Gallstones and cholestasis (COCs may worsen gallstones or cholestasis existing), disorders of the liver and biliary tract (as hepatitis or abnormal liver function).

Skin and appendages:
– FAQ (> 1% and < 10%) : Acne.
– Uncommon (> 0,1% and < 1%) : Rash (urticaria), skin spots, hirsutism (hair growth), alopecia (hair loss).
– Rare (> 0,01% and < 0,1%) : Erythema nodosum ( a type of skin inflammation with nodules on the legs).
– Very rare (< 0,01%) : Erythema multiforme (a type of skin inflammation).

Renal and urinary disorders:
– Very rare (< 0,01%) : HUS (renal disease with blood disorders).

Reproductive system and breast:
– Very common (≥10%) : Stained vaginal bleeding the unexpected.
– FAQ (> 1% and < 10%) : Pain or tightness in chest, breast swelling, mammary secretion, dysmenorrhoea (painful menstruation), changes in menstrual flow, changes in vaginal secretion and cervical ectopia (altering the cervical mucus), amenorrhea (absent menstruation).

General disorders:
– FAQ (> 1% and < 10%) : Fluid retention / edema (swelling), weight changes (gain or loss).

Laboratory Tests:
– Uncommon (> 0,1% and < 1%) : Change in lipid levels in the blood, including hypertriglyceridemia (higher fatty acid levels in blood).

Do not be alarmed by these reactions, since it is quite possible that none of them displayed.
If any of these side effects tell your doctor, who will advise you to stop if it might affect their welfare. If you notice any other effects not listed in this leaflet, check with your doctor or pharmacist.

5. Minesse STORE

Minesse Keep out of the reach and sight of children.
No special storage conditions required.
Minesse not use after the expiry date shown on the packaging.

6. ADDITIONAL INFORMATION

Composition Minesse:

Each yellow coated tablet of Minesse contiene 60 gestodene micrograms of active principle and 15 micrograms of ethinylestradiol active.
The other ingredients are:
– lactose monohydrate
– microcrystalline cellulose
– magnesium stearate
– polacrilina potásica
– OPADRY yellow YS-1-6386-G [hipromelosa, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172)]
– macrogol 1450
– And wax (montana wax glicolada).

Each white film-coated tablet contains no active ingredient but contains:
– lactose monohydrate
– microcrystalline cellulose
– magnesium stearate
– polacrilina potásica
– Opadry white Y-5-18024-A [hipromelosa, hidroxipropilcelulosa, titanium dioxide (E 171), macrogol 400]
– macrogol 1500
– And wax (montana wax glicolada)

Looks like and contents of container
The name of your medicine is Minesse 60 microgramos/15 micrograms presents coated tablets and coated tablets in two colors.
Minesse comes in kits 1 ó 3 blister (the container where the coated tablets) each containing blister 28 coated tablets (24 yellow 4 white).

Holder of the marketing authorization:

Wyeth Farma, SA.

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